FDA Recall
Terminated
Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
Recall: Z-2265-2014
·
Initiated June 30, 2014
Recall
- Recall Number
- Z-2265-2014
- Event Number
- 68738
- Firm
- Synthes, Inc.
- FEI Number
- 3005180112
- Product Code
- HWC
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- June 30, 2014
- Posted
- August 19, 2014
- Terminated
- December 18, 2015
- Address
- 1302 Wrights Ln E, West Chester, PA, 19380-3417
Description
Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
Reason
A screw set was returned from the field for destruction after being exposed to flood water, which was erroneously reprocessed and returned to the field. Initial investigative testing indicated the components within the set may be cytotoxic.
Action
An Urgent Field Safety Notification, dated July 21, 2014, was sent to surgeons explaining the product, problem, and action to be taken with regard to routine post-operative follow-up on patients exposed to the affected product. Questions or concerns should be directed to Leonie Rynn at 610-719-5408 or [email protected].
Distribution
Distributed in the states of WI and MI.
Quantity
4